Under 21 CFR Part 208, FDA can require a Medication Guide when patient labeling could help prevent serious adverse effects, when a drug has a serious risk patients should know about, or when patient adherence is crucial. The manufacturer has to make it available to be distributed with the drug, and for some drugs it is also part of a REMS. In May 2023, FDA proposed replacing Medication Guides and patient package inserts with a one-page Patient Medication Information (PMI) document with four headings: drug name, important safety information, common side effects and directions for use. The comment period closed on November 27, 2023, and the rule had not been finalized when this entry was written.
Why it matters for labeling
A Medication Guide is approved alongside the prescribing information and has to stay consistent with its risk information. When the prescribing information changes after a safety update, the Medication Guide usually has to change too. It travels with the product, either printed in the pack or supplied separately, and it is also carried in the SPL file, so the printed and electronic versions have to match.
Common mistakes
- A Medication Guide not updated after a change to the prescribing information
- An outdated version still being packed or distributed
- The guide missing from the SPL file, or different from the printed version
- Assuming the PMI proposal has already replaced Medication Guides